A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease

NCT02302144 | Completed

• 1 other identifier: BU-SAR-BAL
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to investigate the effects of a theoretically driven, highly challenging exercise program (balance and strengthening exercises) in reducing fall rate, improving balance and reducing fear of falling in persons with Parkinson's disease. In this pilot, randomized, cross-over study, 32 participants with Parkinson disease will be randomly assigned to either an early start (immediately following enrollment) or late start (3 months after enrollment) multifactorial exercise program which will meet 2 times per week for 1.5 hours over 3 months. The exercise program will consist of balance and strengthening exercises which will be individualized depending on the ability of each participant. Fall rate, balance, walking ability, fear of falling, mood, anxiety, and quality of life will be measured prior to the start, at 3 months and 6 months after enrollment. Subjects will be enrolled for 6-7 months.

Conditions

Parkinson Disease

Keywords

Postural Instability (falling); Gait Disturbances (e.g., freezing); Bradykinesia (slowness of movement), rigidity

Outcome Measures

Primary Outcomes (1)

• Falls Diary

  Subjects will be asked to record each falling episode in the falls diary at the time of the fall or as soon as possible in relation to the actual time that the fall occurred. Subjects will be interviewed regarding fall episodes at each treatment session.

  6-7 Months

Secondary Outcomes (15)

• Change in Activities-specific Balance Confidence

  6-7 Months

• Change in Falls Self-Efficacy

  6-7 Months

• Change in Balance Evaluation Systems Test (BESTest)

  6-7 Months

• Change in Six-Minute Walk Test

  6-7 Months

• Change in Freezing of Gait Questionnaire

  6-7 Months

Study Arms (2)

Early Multi-Ex-PD

EXPERIMENTAL

Immediately following enrollment, subjects will participate in a group balance and strengthening program (Multi-Ex-PD) 2x/week for 90 minutes over 3 months within the Center for Neurorehabilitation at Sargent College. Each of the exercises consists of a progression which ranges from less challenging to more challenging. The program will be individualized to the subject to appropriately match their abilities. Each subject will be progressed to a more challenging exercise once specific criteria are met. Resistance for the strengthening exercises will be applied using weighted vests.

Behavioral: Balance & Strengthening Exercises

Late Multi-Ex-PD

EXPERIMENTAL

Three months after enrollment, subjects will participate in a group balance and strengthening program (Multi-Ex-PD) 2x/week for 90 minutes over 3 months within the Center for Neurorehabilitation at Sargent College. Each of the exercises consists of a progression which ranges from less challenging to more challenging. The program will be individualized to the subject to appropriately match their abilities. Each subject will be progressed to a more challenging exercise once specific criteria are met. Resistance for the strengthening exercises will be applied using weighted vests.

Behavioral: Balance & Strengthening Exercises

Interventions

Balance & Strengthening Exercises BEHAVIORAL

Progressive balance and strengthening exercises conducted in a group format yet tailored to each individual

Early Multi-Ex-PD; Late Multi-Ex-PD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a diagnosis of idiopathic Parkinson's disease (using UK Brain Bank Criteria)
• have a Hoehn \& Yahr stage of 2-4 during the "ON" state
• Mini mental status score \> 26
• be 40 years of age or older, so as to represent the typical age range of PD
• be on a stable dose of Parkinson's medications for at least 2 weeks prior to study onset and during the 3 month study period.
• have experienced at least one fall in the past 3 months and greater or equal to 2 falls in the past one-year (A fall was defined as an unexpected event where the person inadvertently came to rest on the ground or other lower level not due to a major intrinsic or extrinsic event)
• able to walk without physical assistance or an assistive device for at least 5 continuous minutes
• able to understand, communicate with and be understood by recruitment personnel
• able to attend the exercise program twice per week at Sargent College
• be interested in participating and provide informed consent

You may not qualify if:

• have a diagnosis of atypical Parkinsonism
• have a Hoehn \& Yahr stage of 1 or 5
• have had previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)
• serious co-morbidities that may interfere with ability to participate in an exercise program (i.e., musculoskeletal, cardiovascular, and neurological (other than Parkinson's))
• be pregnant

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (24)

• Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, Rowe BH. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007146. doi: 10.1002/14651858.CD007146.pub2.

  PMID: 19370674 BACKGROUND

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  PMID: 12023412 BACKGROUND

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  PMID: 15591480 BACKGROUND

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  PMID: 8866492 BACKGROUND

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  PMID: 15031239 BACKGROUND

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  PMID: 17119004 BACKGROUND

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  PMID: 17588236 BACKGROUND

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• Cakit BD, Saracoglu M, Genc H, Erdem HR, Inan L. The effects of incremental speed-dependent treadmill training on postural instability and fear of falling in Parkinson's disease. Clin Rehabil. 2007 Aug;21(8):698-705. doi: 10.1177/0269215507077269.

  PMID: 17846069 BACKGROUND

• Allen NE, Canning CG, Sherrington C, Lord SR, Latt MD, Close JC, O'Rourke SD, Murray SM, Fung VS. The effects of an exercise program on fall risk factors in people with Parkinson's disease: a randomized controlled trial. Mov Disord. 2010 Jul 15;25(9):1217-25. doi: 10.1002/mds.23082.

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  PMID: 16340099 BACKGROUND

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• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

• Sparrow D, DeAngelis TR, Hendron K, Thomas CA, Saint-Hilaire M, Ellis T. Highly Challenging Balance Program Reduces Fall Rate in Parkinson Disease. J Neurol Phys Ther. 2016 Jan;40(1):24-30. doi: 10.1097/NPT.0000000000000111.

  PMID: 26655100 DERIVED

Related Links

• Center for Neurorehabilitation at Boston University

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation; Hypokinesia; Muscle Rigidity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Terry Ellis, PhD, PT, NCS

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Director of Center for Neurorehabilitation

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

US (1)